Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD)

• Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
• Ethical committee approval will be obtained from Ethics committee of General Organization for Teaching Hospitals and Institutes.
• About 50 patients who are candidate to detect the hepato-protective effect of Dapagliflozin on non- alcoholic fatty disease, will be recruited from Alexandria Teaching Hospital (EL-Mery), General Organization for Teaching Hospitals and Institutes.
• All participants should agree to take part in this clinical study and will provide informed consent.
• Demographic data; age (year), sex (female/male), weight (kg), height (cm), BMI (kg/m2) will be collected.
• Venous blood samples (5 ml will be collected by a sterile syringe then placed in a suitable sterile tube to be centrifuged, the serum will be reserved and stored at -80°C until the analysis) before, and after receiving medication (Dapagliflozin).
• Measuring outcome:

• The biochemical tests will be done on the patients are alanine aminotransferase (ALT), aspartate aminotransferase (AST), homeostasis model assessment of insulin resistance (HOMA-IR), Hemoglobin A1C (HbA1C), Low-density lipoproteins (LDL), High-density lipoproteins (HDL), Triglycerides (TG), liver fibrosis score, and complete blood count (CBC).
• The molecular tests will be done on the patient are soluble vascular cell adhesion molecule-1 (Svcam-1), adipocytes (e.g. adiponectin, leptin).
• The ultrasound screening will be done at first examination.
• Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
• Results, conclusion, discussion and recommendations will be given.

Inclusion criteria

• Type 2 diabetes mellitus patients.
• HbA1C < 8.5.
• Patients were They were having fatty liver changes on abdominal ultrasound and mild to moderate elevation of serum liver enzymes.
• BMI more than 30

Exclusion criteria

• Patients with a history of alcohol, smoking, uncontrolled diabetes.
• (HbA1c > 9.0).
• Pregnancy.
• Lactation.
• Hemochromatosis.
• Thyroid disorders.
• Renal dysfunction.
• Cardiac problem.
• Chronic liver and decompensated liver disease in the form of hepatitis B and C.